As the field of health and medicine moves further into the technology information age, research has started to transition from traditional methods to digital methods. Research has been going digital at a steady pace, with an increasing number of clinical trials being conducted via electronic data capture (EDC) systems.
But what exactly are digital clinical trials? In this article, we will explain what digital trials are and what are the differences from decentralized clinical trials. The article will then explain what are the advantages of using a digital trial method, potential challenges and ways to overcome them.
What Are Digital Clinical Trials?
A digital clinical trial leverages new clinical trial technology to support more efficient and cost-effective research. By using cloud computing, wireless monitoring devices, and other emerging technologies, patients can be monitored from remote locations and data transferred securely to a central data repository.
While there are some technical challenges involved in designing digital trials—issues like encrypting participant data during storage, for example—these challenges are being addressed with new technological solutions. Since open-source encryption protocols don’t offer adequate security for researchers who need stronger methods to protect data during storage and transmission (due to sensitive patient information), small companies are turning their focus towards building a new generation of encryption platforms.
Although digital clinical trials do carry some risks, they also offer benefits. Due to advances in medicine and research, many of these risks have decreased over time, and there are now even fewer risks than in traditional clinical trials.
As with any new technology, clinical trials performed digitally do come with some challenges. For example, cloud computing requires continuous monitoring to ensure data integrity and regulatory compliance, which is challenging given that many research institutions lack strong security protocols.
Another key challenge involves ensuring that digital clinical trial devices are compatible across different network providers and devices (e.g., iPhone vs Android). Since these challenges will likely vary depending on which organization conducts research, individual organizations need to test different solutions and identify which will work best for them.
The good news is that many of these issues have already been addressed in traditional clinical trials—such as problems related to electrical interference from wireless hardware—and can easily be applied to a digital trial method.
As researchers become more comfortable with trials performed digitally, they’re also starting to find more innovative ways to use technology. With so much data now available from participants, many trial designers are using big data solutions such as analytics and artificial intelligence (AI) to better understand what works and what doesn’t work in clinical trials.
Because of AI, for example, digital clinical trial platforms can make sense of the huge amount of information generated by hundreds or thousands of people over multiple years. Designers are also experimenting with smart algorithms that can be programmed to predict certain outcomes based on trial subjects’ real-time responses and behavior patterns.
What are the 4 Phases of Clinical Trials?
There are three phases of clinical trials – phase I, phase II, phase III, and phase IV. The phase describes which group of people have been recruited for each type of trial. A clinical trial is a process during which an experimental drug or device (the test) is administered to people with a particular disease or condition (the test subjects).
- Phase I trials typically only test for safety and monitor how many patients can be included in future phases.
- Phase II trials usually include more than 100 patients and gather data on efficacy.
- Phase III trials provide conclusive results.
- Phase IV looks at long term effects of a drug or treatment.
These last studies are typically conducted in several hundred patients and are designed to get approval from regulatory agencies. Phase IV trials, on their side, are post-marketing studies aimed at gathering more information about new medical technologies or medications after they have been approved for use in a specific population of patients. Phase IV trials have no other purpose than to gather more information about a particular medicine or technology’s performance after it has been approved by regulators.
Some clinical trials can also be categorized as borderline or unspecified, since they are not usually referred to a particular phase. Borderline clinical trials aim to gather more information about how well a medication works.
These studies do not include any patients who have been diagnosed with a disease, but instead focus on research subjects that suffer from symptoms associated with several different diseases and conditions. They are conducted before regulators approve a new medication for wider use in the population of patients suffering from such ailments. Unspecified trials refer to any kind of clinical trial that does not fit into one of these categories.
What is a DRM Clinical Trial?
The adoption of digital clinical trials using Data Review Model (DRM) is a relatively new concept. The model has been picked up by many pharmaceutical companies as it provides key advantages over conventional clinical trials like lower costs and less time needed for completion of trials.
Data Review Model (DRM) clinical trials provide full traceability of the data in a clinical trial. Given that clinical trials can be quite costly, each year hundreds of millions of dollars are lost due to process inefficiencies. Additionally, it is estimated that 5 percent of trials go beyond their expected timeline which has led to more and more pharmaceutics companies shifting towards digital technology.
Majorly, there are three types of benefits seen in digital trials:
- Enhanced efficiencies in trial design
- Improved patient recruitment
- Reduced costs associated with traditional clinical trials
With multiple advantages associated with them it’s no surprise why many drug makers are embracing these digital technologies for conducting their research programs.
Another key difference between digital and traditional clinical trials is in trial design. While conventional clinical trials often involve complex stages, which can include different types of testing procedures to confirm treatment outcomes, digital technology has allowed companies to leverage Artificial Intelligence and Predictive Analytics which simplifies trial design.
With increased data comes increased cyber security risks too. In fact, recent surveys suggest that over 40 percent organizations report being victims of some sort of cyber crime each year.
Most clinical trials performed digitally offer cloud based platforms to their study participants. This provides greater convenience and ease of access for participants. However, with increased convenience it also increases challenges associated with security of these data in cloud-based systems.
When considering cyber threats there are two major aspects which need to be addressed: Centralization and Privacy & Confidentiality. These are two areas your research team will need to spend time researching before moving to a cloud-based system.
Differences From Traditional Or Decentralized Clinical Trials
Because traditional clinical trials are controlled and run by a centralized entity, they can be referred to as centralized clinical trials. In these cases, information from all of a study’s participants are gathered together in one place.
However, a decentralized clinical trial stores information from its participants in multiple locations. For example, someone participating in a digital clinical trial may have their physiological readings taken stored with the physiology department while having genetic data pulled from their DNA and stored in another location.
The advantage of decentralized trials is that data is stored across location sources for each participant rather than just being stored in one database to protect against total data loss if all information was stored in the same place.
One advantage of a decentralized trail is that it provides a greater amount of data to researchers. In traditional or centralized clinical trials, data can often be skewed and corrupted because all of it is stored in one place.
On top of that, data security becomes a problem as well when it’s all stored in one database, especially when those databases are maintained by large centralized entities like government agencies. A decentralized trial solves both these problems since no single party stores all of a trial’s information and any suspicious activity is easily caught and addressed before things get out of hand.
There are disadvantages to using performing trials digitally as well. The first disadvantage is that decentralized trials can suffer from low recruitment rates because not everyone wants to have their data stored by so many different sources.
The second potential problem is how digital clinical trials might be viewed by regulators in specific jurisdictions. Regulators may perceive decentralized trials as being less transparent than traditional or centralized clinical trials, which could make it more difficult for them to approve them. However, digital clinical trials offer advantages that traditional and centralized ones simply can’t.
One of the biggest challenges with using a digital trial method is creating a protocol that makes sense for it. In centralized clinical trials, one protocol can be used for all participants. However, when using a digital method for clinical trials, different participants may have to use different protocols depending on their unique genetic makeup and other factors.
A digital trial’s protocol must also take into account storing data from various sources in addition to general participant profiles and preferences. These protocols must be easy enough for participants to understand but also clear enough so that a third party can verify that each individual participant was handled correctly during their trial run. Despite these potential challenges, conducting trials digitally has many advantages over traditional or centralized ones.
Advantages Of Using Digital Trials For Clinical Testing
There are several advantages of using digital trials for clinical testing. The primary benefit is that it will improve transparency and trust among both parties, including patients and pharmaceutical companies. This will also create more convenience, as monitoring can be done on mobile devices by healthcare workers or doctors.
In addition, performing trials digitally can allow sponsors to increase their understanding of target populations through better data tracking and analysis. However, digital trials come with some challenges that need to be overcome in order for it to become widely adopted by stakeholders within the healthcare industry.
Another potential problem is related to trust. Patients who are used to traditional forms of clinical testing may feel uneasy about using a digital trial method. More studies need to be done regarding its effectiveness and how it can improve patient care and treatment so more people will eventually get on board with it.
For now, researchers recommend that more education programs should be established for healthcare workers as well as for patients themselves so they will know what it is and how it works.
Another challenge is in regard to legal matters. Without a standard of evidence established for using a digital trial method, it is difficult to determine which type of clinical research should be applied for specific studies. In order to address these issues, stakeholders must find ways to create standards in terms of data privacy and security for a digital trial method. They also need to establish whether or not there should be differences when it comes to dealing with traditional and decentralized clinical trials, as well as how they can work together when relevant topics arise.
New Clinical Trials Technology
Today’s digital age has given rise to a new era of clinical trials technology. Today, there are technological advancements that weren’t possible before now. One of these enhancements is digital clinical trials, which allows researchers to collect data digitally.
This enables them to connect directly with participants at any time, share information, and make treatment decisions instantly. In addition, it also offers improved patient experience through collaboration across multiple sites.
By bettering communication and reducing costs, digital trials have taken research in new directions. With today’s technology and mobile applications (apps), researchers can make adjustments quickly based on collected data from participants who aren’t always physically at a site location for treatment or follow-up care because they can be located remotely.
By using digital clinical trials, researchers are able to quickly collect data and make changes, resulting in less costs and better treatments. With traditional methods of collecting data, participants must be located at a site where researchers can administer treatment.
This doesn’t allow for real-time adjustments based on collected data and is often inefficient because it can require more time and money to travel back and forth between locations to collect information that may or may not need adjusting. It also limits communication with patients because they have to physically visit a research site where researchers are located instead of interacting online on their own terms outside of normal office hours.
Digitalization transforms how clinical trials are conducted: The increased use of technology in clinical trials has shifted how they are conducted from both an operational and medical perspective.
Just as today’s technology has improved communication and collaboration across different locations, digital clinical trials have created new opportunities to enhance research by improving communication with patients. Due to their remote location, they may not be able to visit a research site or participate in traditional trial activities.
When these individuals participate in a digital clinical trial, they can interact with researchers at any time of day or night. This allows them more input on treatment decisions than if they were visiting a site at set hours.
With an app-based clinical trial that is accessible on mobile devices, participants can provide information wherever they are instead of needing to make time for travel back and forth between visits or hold meetings at specific times outside of normal office hours.
Pros and Cons of Digital Clinical Trials
Creating a new trial from scratch is costly and time-consuming. Disruptive technologies, such as digital trials, can drastically reduce barriers to clinical trial participation and increase speed to market. However, there are pros and cons associated with performing a digital trial that companies must consider before implementing them. While each company will have different business goals for adopting a digital trial strategy, it’s important to review both sides of any decision before finalizing your strategy.
First, digital trials are cost-effective. They can easily scale from a small pool of participants to hundreds or thousands of patients. Also, there is no need for physical storage space and related infrastructure costs, as data is stored electronically.
This allows companies to eliminate significant expenses on paper and printing fees, which can be a major expense when conducting clinical trials. Digital trials also carry some disadvantages. One of these disadvantages is that they require internet access at all times in order to provide real-time data analysis, which can pose a major challenge in emerging markets where internet connectivity may not be readily available or reliable.
Another potential drawback is that of security and data integrity. The success of using a digital method relies on a secure internet connection at all times, but if any issues arise in regards to security, patient data may be compromised.
Companies can overcome these disadvantages by implementing an effective strategy that ensures patients have access to the internet throughout their participation in clinical trials. They should also verify that proper safeguards are in place to ensure data integrity is upheld at all times. Once you have weighed both sides of each pros and cons decision and decided if a digital trial method is right for your research team.